- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07657390
Prospective Randomized Controlled Clinical Study of Acupoint Application With Gutong Plaster in the Treatment of Moderate to Severe Cancer Pain
A Prospective Randomized Controlled Clinical Trial of Acupoint Application With Gutong Plaster for Moderate to Severe Cancer Pain
This clinical trial aims to evaluate the efficacy and safety of acupoint application with Gutong Plaster for treating moderate to severe cancer pain in patients aged ≥18 years with moderate to severe cancer pain (NRS 4-8), ECOG 0-3, life expectancy ≥3 months. The main questions it aims to answer are:
Does acupoint application with Gutong Plaster improve the response rate (CR + PR) in patients with moderate to severe cancer pain? Does Gutong Plaster reduce pain intensity (NRS score) and opioid consumption in cancer pain patients? Researchers will compare patients receiving oxycodone plus Gutong Plaster to patients receiving oxycodone plus placebo simulant to see if Gutong Plaster provides better pain relief and lower opioid use.
Participants will:
Receive standard treatment with oxycodone prolonged-release tablets Be randomly assigned to receive Gutong Plaster or placebo simulant via acupoint application twice daily for 14 days Undergo pain assessment, quality of life evaluation, safety laboratory tests, and follow-up at specified time points
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jinyuan Chang
- Número de teléfono: 86+13261804346
- Correo electrónico: jychangncc@163.com
Ubicaciones de estudio
-
-
-
Beijing, Porcelana, 100700
- Reclutamiento
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
-
Contacto:
- Jinyuan Chang
- Número de teléfono: 86+13261804346
- Correo electrónico: jychangncc@163.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- The subject has signed the informed consent form.
- Age ≥ 18 years, including males and females.
- According to the investigator's assessment, the subject has relatively stable cancer pain and requires continuous analgesic medication (estimated treatment duration ≥ 2 weeks).
- Estimated life expectancy ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3.
- Adequate organ function.
- Patients with moderate to severe cancer pain, defined as 4 ≤ NRS (Numeric Rating Scale) score ≤ 8.
Exclusion Criteria:
- Known allergy to any active ingredient or excipient of the study drug, or a history of allergy to other opioids and their related components.
- Persistent pain caused by other diseases or unknown causes.
- Subjects presenting with urgent symptoms such as intestinal obstruction/perforation, spinal cord compression, or pathological fracture.
- History of severe psychiatric disorders, such as schizophrenia and depression.
- Patients currently receiving chemotherapy or still in the chemotherapy reaction period (patients in the chemotherapy interval may be included. That is, patients who have completed chemotherapy for more than 1 week can be enrolled, or patients who have just finished chemotherapy may be enrolled at the investigator's discretion).
- Patients who have received radiotherapy to the pain area within 4 weeks before enrollment (those who have received radiotherapy to areas other than the pain area may be included), or those who plan to receive radiotherapy to the pain area during the study.
- Other conditions deemed unsuitable for participation in this study by the investigator, such as poor compliance.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Experimental
The experimental group received Gutong Plaster treatment.
Herbal raw materials were supplied by the Pharmacy of Cancer Hospital, Chinese Academy of Medical Sciences, and processed into powder at the South District of Sihui Hospital.
The powder was crushed, sieved and packaged in 10-gram sachets.
|
When in use, the Gutong Plaster powder is evenly mixed with petrolatum at a ratio of 2:1, then spread uniformly on medical breathable adhesive plasters (blank three-volt patch bases).
The patches are applied to the following acupoints: Tianshu (ST25) and Guanyuan (CV4) for warming yang and tonifying qi; Fenglong (ST40), Xuehai (SP10), and Sanyinjiao (SP6) for removing blood stasis and detoxification.
|
|
Comparador de placebos: placabo
The placebo group was treated with Gutong Plaster placebo.The matching placebo for the Gutong Plaster is composed of 1/20 of the Gutong Plaster's raw materials plus yellow corn flour, and its preparation method refers to The Preparation Technology of Placebo for External Chinese Medicine Powders.
All study medications are uniformly prepared, numbered, and distributed by the research team, and stored at room temperature in a dry environment.
|
When in use, the Gutong Plaster powder is evenly mixed with petrolatum at a ratio of 2:1, then spread uniformly on medical breathable adhesive plasters (blank three-volt patch bases).
The patches are applied to the following acupoints: Tianshu (ST25) and Guanyuan (CV4) for warming yang and tonifying qi; Fenglong (ST40), Xuehai (SP10), and Sanyinjiao (SP6) for removing blood stasis and detoxification.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Response rate : Defined as the sum of the complete response (CR) rate plus the partial response (PR) rate. Partial response is defined as a reduction of 50% or more in the pain score from baseline to post-treatment.
Periodo de tiempo: From baseline to Day 14
|
From baseline to Day 14
|
Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 25/649-5595
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .